Varying progress with implementing the EU Falsified Medicines Directive (FMD) across different Member States and different sectors of the medicines supply chain has been highlighted at a conference in Estonia.
The meeting, hosted by the Estonian Presidency of the Council of Europe, brought together representatives from National Medicines Verification Organisations (NMVOs), the European Medicines Verification Organisation (EMVO), Member States and trade bodies. Raj Patel, Chair of the UK FMD Working Group for Community Pharmacy and President of the Pharmaceutical Group of the European Union (which represents community pharmacy organisations), was among the UK’s representatives.
With exactly 15 months to go before the deadline imposed by EU Delegated Regulation 2016/161, the conference heard that while most Member States now have a functioning NMVO, a few have still to appoint their IT Blueprint Service Provider. Progress with connecting manufacturers to the central “hub” (the EMVS) through which they upload the unique identifiers used to determine the authenticity of medicines, is also behind schedule with fewer than 300 of the expected 2,500 connected so far, well behind the planned target of 1,900 by the end of 2017.
Some countries, including Ireland, Germany and Sweden, are making good progress. They have set up their NMVSs and are planning to start pilot testing with selected pharmacies, wholesalers and hospitals in early 2018.
The spectre of Brexit still hangs over the UK’s progress with implementing FMD. Although the UK Government maintains that it is committed to implementing FMD by February 2019, before the UK leaves the European Union at the end of March 2019, uncertainty over what will happen afterwards has delayed progress and the UK has fallen back compared with other countries.